A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01529515
First received: February 6, 2012
Last updated: May 26, 2014
Last verified: May 2014

February 6, 2012
May 26, 2014
May 2012
April 2014   (final data collection date for primary outcome measure)
The time to first relapse event in the Double-blind Phase [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
Time to relapse is defined as the time between randomization to treatment in the Double-Blind Phase and the first documentation of a relapse.
Same as current
Complete list of historical versions of study NCT01529515 on ClinicalTrials.gov Archive Site
  • The change in score from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) (total and subscales) in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ Designated as safety issue: No ]
    PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme).
  • The change from baseline to endpoint in Clinical Global Impression Severity (CGI-S) scale in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ Designated as safety issue: No ]
    The CGI-S rating scale is used to rate the severity of a patient's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
  • The change from baseline to endpoint in Personal and Social Performance (PSP) scale in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ Designated as safety issue: No ]
    The PSP scale measures personal and social functioning in the domains of: a) socially useful activities, b) personal and social relationships, c) self-care, and d)disturbing and aggressive behavior.
  • The change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) (total and subscales) in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ Designated as safety issue: No ]
    The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme).
  • The change from baseline to endpoint in Clinical Global Impression Severity (CGI-S) scale in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ Designated as safety issue: No ]
    The CGI-S rating scale is used to rate the severity of a patient's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
  • The change from baseline to endpoint in Personal and Social Performance (PSP) scale in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ Designated as safety issue: No ]
    The PSP scale measures personal and social functioning in the domains of: a) socially useful activities, b) personal and social relationships, c) self-care, and d)disturbing and aggressive behavior.
Not Provided
Not Provided
 
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia

The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: PP3M 175 mg eq.
    Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
  • Drug: PP3M 263 mg eq.
    Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
  • Drug: PP3M 350 mg eq.
    Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
  • Drug: PP3M 525 mg eq.
    Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
  • Drug: Placebo (20% Intralipid emulsion)
    Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
  • Experimental: Paliperidone palmitate 3-month (PP3M)
    Interventions:
    • Drug: PP3M 175 mg eq.
    • Drug: PP3M 263 mg eq.
    • Drug: PP3M 350 mg eq.
    • Drug: PP3M 525 mg eq.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo (20% Intralipid emulsion)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with schizophrenia for more than 1 year
  • A total score in the Positive and Negative Syndrome Scale (PANSS) < 120
  • Signed informed consent
  • Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
  • Men must agree to use a double-barrier method of birth control
  • Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
  • A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
  • Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
  • A diagnosis of substance dependence within 6 months before screening
  • History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
  • Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
  • Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
  • Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Malaysia,   United States,   Colombia,   Korea, Republic of,   Ukraine,   Mexico,   Romania,   Turkey
 
NCT01529515
CR100717, R092670PSY3012, 2011-004676-11, U1111-1135-1969
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP